Syndesmosis Ankle Study

Kyle Schweser MD

Status: Completed

Conditions: Weight-bearing Status; Syndesmotic Disruption

Treatments: Other: Early Weight-Bearing; Other: Delayed/Late Weight-Bearing

Study type: Interventional

Funder types: Other

Identifiers

NCT03970603

2014428

Details and patient eligibility

About

A debate regarding ankle fracture fixation centers on time to weight bearing. Recent literature has supported immediate weight bearing in surgically stabilized ankle fractures. However, significant variation among orthopaedic surgeons persists, and weight bearing recommendations change when there is a syndesmotic disruption. There is very little literature on time to weight bearing, with most available series casting/immobilizing these injuries for 6 weeks after fixation. There is very little data examining post-operative weight bearing after syndesmotic stabilization, and the majority centers on screw fixation. The minimum time to weight bearing after an ankle fracture with syndesmotic fixation in the literature is 4 weeks, with most focusing on 6 to 12 weeks. Based on biomechanical data regarding suture button techniques, the investigators hypothesize that patients undergoing ankle fracture fixation plus suture button fixation of their syndesmotic disruption will be able to safely bear weight early (2 weeks) after surgery. The investigator's null hypothesis is that there will be no difference between early weight bearing (2 weeks), and late weight bearing (6 weeks) in terms of outcome, hardware failure, loss of reduction, and return to work.

Adult patients who have an ankle fracture with suspected syndesmotic disruption, requiring a suture button fixation operative intervention will be randomized into early (2 weeks post-surgically) weight-bearing status or delayed weight-bearing status (non-weight-bearing for 6 weeks following fixation).

Primary objective: Maintenance of ankle reduction at 1 year follow-up (measured by comparing immediate post-op CT and 1 year time-point CT).

Secondary Objectives: Pain scores, surgical experience, work productivity and activity impairment , AAOS foot and ankle scores (2w, 6w, 12w, 6m, 1y), use of assistive devices, range of motion, physical therapy requirement/length of use/compliance, post-operative protocol compliance, post-operative complications (wound healing, infection, implant failure, fracture healing).

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18 years of age or older
2. Ankle fracture with suspected syndesmotic disruption that would likely be treated with suture button fixation operative intervention
3. Ability to ambulate preoperatively

Exclusion criteria

1. Younger than 18
2. Length unstable syndesmotic injury (i.e. Maisonneuve)
3. Neuropathic diabetics
4. 325 pounds or more
5. Prisoner
6. Pregnant or lactating
7. End stage renal disease
8. Inability to follow commands (dementia, TBI, etc.)
9. Polytrauma patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Early Weight-Bearing

Active Comparator group

Description:

Being directed to bear weight on the affected ankle two weeks from suture button fixation for syndesmotic disruption

Treatment:

Other: Early Weight-Bearing

Delayed/Late Weight-Bearing

Active Comparator group

Description:

Being directed to bear weight on the affected ankle six weeks from suture button fixation for syndesmotic disruption

Treatment:

Other: Delayed/Late Weight-Bearing